Effects of C-MAC Videolaryngoscope, McGRATH Videolaryngoscope and Macintosh Direct Laryngoscope on Intraocular Pressure and Hemodynamics

• Sponsor: Inonu University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03589638
• Collaborator: (none)
• Enrollment: 3
• Location: 1
• Arms: 3
• Actual Duration (Months): 1.6
• Patients Per Site Per Month: 1.9

Study Details

Study Description

Brief Summary

In this study, participants aimed to compare the effects of direct laryngoscopic endotracheal intubation and videolaryngoscopic intubation with C-MAC videolaryngoscope and McGrath videolaryngoscope on intraocular pressure and hemodynamics.

Condition or Disease	Intervention/Treatment	Phase
Anesthesiology Devices Associated With Adverse Incidents; Intraocular Pressure	Device: Direct laryngoscope; Device: C-MAC videolaryngoscope; Device: McGrath videolaryngoscope	N/A

Detailed Description

The maintenance of airway opened is one of the main responsibility of the anesthetist. Intubation procedure during anesthesia application benefits such as airway opening, airway and breathing control, aspiration hazard, respiratory effort and dead space reduction, surgical comfort and airway control during resuscitation. Laryngoscopy and tracheal intubation increases in heart rate, blood pressure and the intraocular pressure. The sympathetic-adrenal activity caused by the stimulation of the laryngeal and tracheal tissues is responsible for these negative effects. Endotracheal intubation with videolaryngoscopy is an alternative method used in airway management. Laryngoscopy and tracheal intubation under general anesthesia and laryngeal mask and airway control techniques cause different hemodynamic and catecholamine levels.

Study Design

• Study Type: Interventional
• Actual Enrollment: 3 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Prospective, Randomized, double blind Clinical TrialProspective, Randomized, double blind Clinical Trial
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Effects of C-MAC Videolaryngoscope, McGRATH Videolaryngoscope and Macintosh Direct Laryngoscope on Intraocular Pressure and Hemodynamics; a Randomized, Double-blind Clinical Trial
• Actual Study Start Date: Jun 20, 2018
• Actual Primary Completion Date: Aug 8, 2018
• Actual Study Completion Date: Aug 8, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: direct laryngoscope Endotracheal intubation was applied by anesthesiologist with direct laryngoscope.	Device: Direct laryngoscope; Endotracheal intubation was applied by anesthesiologist wtih direct laryngoscope. SAP (systolic arterial pressure), DAP (diastolic arterial artery pressure), MAP (mean arterial pressure) were measured before and 5 minutes after intubation, , Heart rate (HR), SPO2 (oxygen saturation by pulse oximetry), PI (perfusion index), and intraocular pressure values measured by the eye clinician using the device.; Device: C-MAC videolaryngoscope; Endotracheal intubation was applied by anesthesiologist wtih direct laryngoscope. SAP (systolic arterial pressure), DAP (diastolic arterial artery pressure), MAP (mean arterial pressure) were measured before and 5 minutes after intubation, , Heart rate (HR), SPO2 (oxygen saturation by pulse oximetry), PI (perfusion index), and intraocular pressure values measured by the eye clinician using the device.; Device: McGrath videolaryngoscope; Endotracheal intubation was applied by anesthesiologist wtih direct laryngoscope. SAP (systolic arterial pressure), DAP (diastolic arterial artery pressure), MAP (mean arterial pressure) were measured before and 5 minutes after intubation, , Heart rate (HR), SPO2 (oxygen saturation by pulse oximetry), PI (perfusion index), and intraocular pressure values measured by the eye clinician using the device.
Active Comparator: C-MAC videolaryngoscope Endotracheal intubation was applied by anesthesiologist with C-MAC videolaryngoscope.	Device: Direct laryngoscope; Endotracheal intubation was applied by anesthesiologist wtih direct laryngoscope. SAP (systolic arterial pressure), DAP (diastolic arterial artery pressure), MAP (mean arterial pressure) were measured before and 5 minutes after intubation, , Heart rate (HR), SPO2 (oxygen saturation by pulse oximetry), PI (perfusion index), and intraocular pressure values measured by the eye clinician using the device.; Device: C-MAC videolaryngoscope; Endotracheal intubation was applied by anesthesiologist wtih direct laryngoscope. SAP (systolic arterial pressure), DAP (diastolic arterial artery pressure), MAP (mean arterial pressure) were measured before and 5 minutes after intubation, , Heart rate (HR), SPO2 (oxygen saturation by pulse oximetry), PI (perfusion index), and intraocular pressure values measured by the eye clinician using the device.; Device: McGrath videolaryngoscope; Endotracheal intubation was applied by anesthesiologist wtih direct laryngoscope. SAP (systolic arterial pressure), DAP (diastolic arterial artery pressure), MAP (mean arterial pressure) were measured before and 5 minutes after intubation, , Heart rate (HR), SPO2 (oxygen saturation by pulse oximetry), PI (perfusion index), and intraocular pressure values measured by the eye clinician using the device.
Active Comparator: McGrath videolaryngoscope Endotracheal intubation was applied by anesthesiologist with McGrath videolaryngoscope.	Device: Direct laryngoscope; Endotracheal intubation was applied by anesthesiologist wtih direct laryngoscope. SAP (systolic arterial pressure), DAP (diastolic arterial artery pressure), MAP (mean arterial pressure) were measured before and 5 minutes after intubation, , Heart rate (HR), SPO2 (oxygen saturation by pulse oximetry), PI (perfusion index), and intraocular pressure values measured by the eye clinician using the device.; Device: C-MAC videolaryngoscope; Endotracheal intubation was applied by anesthesiologist wtih direct laryngoscope. SAP (systolic arterial pressure), DAP (diastolic arterial artery pressure), MAP (mean arterial pressure) were measured before and 5 minutes after intubation, , Heart rate (HR), SPO2 (oxygen saturation by pulse oximetry), PI (perfusion index), and intraocular pressure values measured by the eye clinician using the device.; Device: McGrath videolaryngoscope; Endotracheal intubation was applied by anesthesiologist wtih direct laryngoscope. SAP (systolic arterial pressure), DAP (diastolic arterial artery pressure), MAP (mean arterial pressure) were measured before and 5 minutes after intubation, , Heart rate (HR), SPO2 (oxygen saturation by pulse oximetry), PI (perfusion index), and intraocular pressure values measured by the eye clinician using the device.

Outcome Measures

Primary Outcome Measures

1. intraocular pressure [From beginning of Anesthesia to 10th minute of surgery]

   The relevant values will be measured in the determined time.

Secondary Outcome Measures

1. mean arterial pressure [From beginning of Anesthesia to 10th minute of surgery]

   The relevant values will be measured in the determined time.

2. systolic arterial pressure [From beginning of Anesthesia to 10th minute of surgery]

   The relevant values will be measured in the determined time.

3. diastolic arterial pressure [From beginning of Anesthesia to 10th minute of surgery]

   The relevant values will be measured in the determined time.

4. heart rate [From beginning of Anesthesia to 10th minute of surgery]

   The relevant values will be measured in the determined time.

5. peripheral oxygen saturation [From beginning of Anesthesia to 10th minute of surgery]

   The relevant values will be measured in the determined time.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• American Society of Anesthesiologist Score 1-2

• Mallampati 1 ve 2

Exclusion Criteria:

• Glaucoma,

• Diabetes mellitus

• Cardiovascular and pulmonary disease

• American Society of Anesthesiologist Score III-IV

• Bdoy mass index greater than 35

• Difficult intubation history

• Obstetric surgery

• Propofol, fentanyl, rocuronium contraindication

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Inonu University Medical Faculty	Malatya		Turkey	44090

Sponsors and Collaborators

• Inonu University

Investigators

• Principal Investigator: Ahmet Selim Ozkan, MD, İnönü Üniversitesi Tıp Fakültesi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ahmet Selim Ozkan, Department of anesthesia, Inonu University
• ClinicalTrials.gov Identifier: NCT03589638
• Other Study ID Numbers: Asozkan 6
• First Posted: Jul 18, 2018
• Last Update Posted: Jul 22, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Ahmet Selim Ozkan, Department of anesthesia, Inonu University: tracheal intubation; videolaryngoscopy; hemodynamics; intraocular pressure

Study Results

No Results Posted as of Jul 22, 2021